FDA.reportPublic FDA data

Flawless Effect Liquid Foundation SPF 15

Product NDC
57627-113
11-digit product format
576270113
Labeler code
57627
Product ID
57627-113_5da9858b-49e3-023c-e063-6294a90a6d18
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OXYBENZONE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-04-25
Substance
OXYBENZONE; OCTINOXATE
Active strength
.9; 2.25 g/30g; g/30g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Flawless Effect Liquid Foundation SPF 15
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OXYBENZONE.9 g/30g
OCTINOXATE2.25 g/30g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-113-01Flawless Effect Liquid Foundation SPF 15Merle Norman30 g in 1 BOTTLELIQUID3019
57627-113-02Flawless Effect Liquid Foundation SPF 15Merle Norman1 in 1 CARTONLIQUID119

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
OCTINOXATEACTIVE MOIETY4Y5P7MUD51FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
OXYBENZONEACTIVE MOIETY95OOS7VE0YFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
ALUMINUM STARCH OCTENYLSUCCINATEINACTIVE INGREDIENTI9PJ0O6294FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CAMELLIA OLEIFERA LEAFINACTIVE INGREDIENT5077EL0C60FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CHAMOMILEINACTIVE INGREDIENTFGL3685T2XFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
CYCLOMETHICONE 6INACTIVE INGREDIENTXHK3U310BAFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
DISODIUM STEAROYL GLUTAMATEINACTIVE INGREDIENT45ASM2L11MFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
ETHYLHEXYL PALMITATEINACTIVE INGREDIENT2865993309FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
FERROUS OXIDEINACTIVE INGREDIENTG7036X8B5HFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GINKGOINACTIVE INGREDIENT19FUJ2C58TFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GLYCERYL 1-OLEATEINACTIVE INGREDIENTD3AEF6S35PFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
MICAINACTIVE INGREDIENTV8A1AW0880FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
MYRISTYL MYRISTATEINACTIVE INGREDIENT4042ZC00DYFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PEG-30 DIPOLYHYDROXYSTEARATEINACTIVE INGREDIENT9713Q0S7FOFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZGFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
TETRAHEXYLDECYL ASCORBATEINACTIVE INGREDIENT9LBV3F07AZFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPFLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-113FLAWLESS EFFECT LIQUID FOUNDATION SPF 15 MERLE NORMAN (OCTINOXATE, OXYBENZONE) LIQUID [MERLE NORMAN]18Current NDC, Legacy NDC, 2 package rows20241004_05615352-186b-4610-a719-16fc36e09bb3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 90 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO ULTIMATE SUN PROTECTOROCTISALATE, TITANIUM DIOXIDE, OCTOCRYLENE, AND ZINC OXIDESHISEIDO AMERICAS CORPORATIONc656792a-e1ed-478d-b501-9bdc92d16eca2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 110 ALABASTEROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION0a214b6b-69a7-4cb9-9095-6fcf2b6945de2026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN SELF-REFRESHING FOUNDATION 430 CEDAROCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfb6ac681-ff74-4420-a4f6-843d5f2b6d6b2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION207e2035-5f31-4745-a801-b386b040b7382026-01-05WarningsExact identifier
application number: M020
Hawaiian Blend Essential Zinc SPF 50ZINC OXIDE, TITANIUM DIOXIDEThe Islander Group47aa8605-e536-b998-e063-6394a90ad9f02026-01-05WarningsExact identifier
application number: M020
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHTOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbf736c5b-fc33-4cd5-8d18-03929f739d762026-01-05WarningsExact identifier
application number: M020
SHISEIDO FUTURE LX TOTAL RADIANCE FOUNDATION E Golden 1OCTINOXATESHISEIDO AMERICAS CORPORATION8a9294c2-3933-4f9c-b7e6-1f446f441a162026-01-05WarningsExact identifier
application number: M020
Shiseido Future Solution LX Total ProtectiveAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION6de17911-4bce-46c9-906b-07d899a36ceb2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE RADIANT CORRECTOR FOR EYES IVORYOCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONc4028089-677f-4d51-9c8b-3892ff1649e02026-01-05WarningsExact identifier
application number: M020
SHISEIDO SYNCHRO SKIN RADIANT LIFTING FOUNDATION 110OCTINOXATE AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION8a0da327-a805-4ef9-b69a-14bf7278a81a2026-01-05WarningsExact identifier
application number: M020
CLE DE PEAU BEAUTE CORRECTING VEIL nENSULIZOLE, OCTINOXATE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONfd9b42e4-6f9d-45a9-bee3-ac1bc4b352522026-01-05WarningsExact identifier
application number: M020
SHISEIDO THE MAKEUP FOUNDATION I20TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATION3c024fe9-2983-4857-a55a-13406158e3a92026-01-05WarningsExact identifier
application number: M020
cle de peau BEAUTE RADIANT FLUID FOUNDATION BF10TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONb2b55a7a-1f68-429d-ba70-5bb6c7e0d8d32026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 BERRY BALMYZINC OXIDEKao USA Inc.26bcb9cd-bfb5-998c-e063-6394a90ab9d62026-01-05WarningsExact identifier
application number: M020
HELLO SUNDAY THE MINERAL LIP ONE NOURISHING LIP TINT SPF 45 VANILLA CLOUDZINC OXIDEKao USA Inc.26cf1320-aae5-2ea0-e063-6394a90a3be22026-01-05WarningsExact identifier
application number: M020
OZE SUN BONDIZINC OXIDE SUNSCREENVEGANIC SKN LIMITED47b1aae6-0b86-7d48-e063-6294a90a9ece2026-01-05WarningsExact identifier
application number: M020
Hybrid SPF SPF 30OCTOCRYLENE, OCTISALATE, ZINC OXIDETopiderm, Inc.5c99f98c-025c-4886-824f-af968033baf42026-01-05WarningsExact identifier
application number: M020
TRICK AND TREAT CC2 - Active Moisturizing Color Correcting Broad-Spectrum SPF 46 PlusTITANIUM DIOXIDEHEY HONEY INC.21187805-fae9-476c-81b0-27ffeb0b99112026-01-05WarningsExact identifier
application number: M020
VEAKSON BEEF TALLOW SUNSCREENZINC OXIDE,PHENYLBENZIMIDAZOLE SULFONIC ACIDGuangdong Aimu Biological Technology Co., Ltd473c241a-1258-1680-e063-6394a90a7d982026-01-04WarningsExact identifier
application number: M020
HYDRATING SUNSCREENHYDRATING SUNSCREENGuangzhou Yapeng Refinement Chemical Co., Ltd.19a3687b-32b0-7c83-e063-6294a90aaf812026-01-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-113-015762701130130 g in 1 BOTTLE30 gHistorical
57627-113-02576270113021 BOTTLE in 1 CARTON (57627-113-02) / 30 g in 1 BOTTLE (57627-113-01) 1 bottle2011-04-250000-00-00NoNoCurrent